Sun Pharmaceutical DOXOrubicin Liposome Injection Recall: Lack of Sterility Assurance
Sun Pharmaceutical recalls DOXOrubicin Hydrochloride Liposome Injection vials due to lack of sterility assurance. This could lead to infections if the product is not properly sterilized during manufacturing.
Recall notice
Lack Of Assurance Of Sterility
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling DOXOrubicin Hydrochloride Liposome Injection vials because they may not be sterile. Using these vials could lead to infections if the product is contaminated. Read more at govinfonow.com/recall/40930-sun-pharmaceutical-doxorubicin-liposome-injection-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/40930-sun-pharmaceutical-doxorubicin-liposome-injection-recall-lack-of-sterility-assurance · Updated October 7, 2026 · FDA enforcement record: FDA #D-0229-2018
Cite this page
“Sun Pharmaceutical DOXOrubicin Liposome Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40930-sun-pharmaceutical-doxorubicin-liposome-injection-recall-lack-of-sterility-assurance. Based on FDA recall #D-0229-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0229-2018%22&limit=1).
Why it’s dangerous
The product may not be sterile during manufacturing, which could lead to infections if the vial is contaminated. This is a serious risk for patients undergoing chemotherapy.
Who’s affected
Patients receiving chemotherapy treatments who use this specific vial product are affected. Healthcare providers administering the drug are also at risk.
How to tell if you have this one
Check for the product name DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial. The NDC code is 47335-049-40 and the lot number is JKS0403A (expires 02/2019).
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 47335-049-40 and lot number JKS0403A on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states there is a lack of assurance of sterility, so the product may not be safe to use and could cause infections.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0229-2018 (January 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0229-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.